SotorasibLumakras
Treatment of patients with non-squamous or not otherwise specified (NOS) Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) who harbour the KRAS G12C variant and who have progressed on prior therapy.
Decisions on record
- Meeting Nov 2022 Withdrawn KRAS G12C variant non-small cell lung cancer no PSD
- Meeting Mar 2022 Not recommended Non-small cell lung cancer
Access path
- TGA registered · Lumakras
TGA label narrower than the PBS population
- Mar 2022Not recommended
vs docetaxel
From the public summary
7.1 The PBAC decided not to recommend sotorasib for the treatment of non-squamous or not otherwise specified (NOS) Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) who harbour the KRAS G12C variant and who have progressed on prior therapy. The PBAC considered it was likely that sotorasib provided some clinical benefit over docetaxel but the magnitude of the benefit was highly 46PSD · Mar 2022
7.2 The PBAC noted the consumer comments were supportive of making sotorasib available as a treatment option. The PBAC acknowledged there was a moderate clinical need for additional therapies for NSCLC, given the availability of other treatment options.PSD · Mar 2022
6.56 The submission presented a modelled economic evaluation, based on an unanchored MAIC of single-arm studies comparing sotorasib and docetaxel in a population of patients with KRAS G12C NSCLC (i.e. treatment-only). The model however did allow a test-treatment structure to be explored.PSD · Mar 2022
6.57 The assumption that testing is associated with no additional cost may not be reasonable. PASC noted that most testing of KRAS in Australia is done using NGS with gene panels, though noted that some smaller laboratories may still be using single gene testing (1669 Ratified PICO).PSD · Mar 2022
6.2 The PBAC noted and welcomed the input from a consumer group (1), a health care professional (1) and an organisation (1) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with sotorasib including an additional choice of therapy, an oral treatment regimen, longer overall survival, and quality of life benefits because sotorasib is better tolerated than chemotherapy by most patients.PSD · Mar 2022
6.3 The Medical Oncology Group of Australia (MOGA) also expressed its strong support for the sotorasib submission, categorising it as one of the therapies of “high priority for PBS listing” on the basis of the CodeBreak100 trial.PSD · Mar 2022
6.90 No risk sharing arrangement was proposed in the submission. However, the sponsor indicated that they would be willing to agree to a financial cap arrangement for sotorasib that appropriately shares financial risk with government to reduce uncertainty associated with the prevalence of KRAS G12C in the Australian setting, the proportion of patients who receive a second-line therapy, and the duration of sotorasib therapy.PSD · Mar 2022
Cost-effectiveness
ICER value is redacted/commercially sensitive — the economic evaluation section is cut off in the provided text.
Decision context
PopulationAdults with previously treated (progressed on prior therapy) non-squamous or NOS NSCLC with KRAS G12C variant, WHO performance status ≤2, Stage IIIB or Stage IV disease.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2022 | Not recommended | docetaxel | — | Single-arm · ORR |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| CodeBreak 100 | Ph 1, PHASE2 | 713 | Primary: Number of subjects with treatment-emergent adverse events | active not recruiting |
| CodeBreak 200 | Ph 3 | 345 | Progression-free Survival (PFS) | active not recruiting |
Codependent tests
| Service | Biomarker | MSAC outcome | Year |
|---|---|---|---|
| KRAS G12C variant testing for sotorasib eligibility in NSCLC | KRAS G12C variant | deferred | 2022 |
Consumer voice
Consumer input described benefits of sotorasib treatment including an additional therapy choice, oral regimen, longer overall survival, and improved quality of life due to better tolerability compared to chemotherapy. The Medical Oncology Group of Australia expressed strong support for PBS listing.
The comments described a range of benefits of treatment with sotorasib including an additional choice of therapy, an oral treatment regimen, longer overall survival, and quality of life benefits because sotorasib is better tolerated than chemotherapy by most patients. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to second-line (≥1 prior therapy) and non-squamous/NOS histology; TGA label permits any histology.